Veracyte Launches Early Access Program for Envisia Genomic Classifier to Improve Diagnosis of IPF

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 17, 2018--
Veracyte,
Inc. (Nasdaq: VCYT) today announced that it has launched an Early
Access Program to begin making the Envisia Genomic Classifier available
to patients being evaluated for interstitial lung diseases (ILD),
including idiopathic pulmonary fibrosis (IPF). Physicians from Jefferson
(Philadelphia University + Thomas Jefferson University), Keck Medicine
of USC, Providence Sacred Heart Medical Center in Washington state and
University of California, Los Angeles (UCLA) are among the first to
participate in the program, offering patients the new genomic test to
enable more confident IPF diagnoses and help ensure optimal treatment –
without the need for surgery.

“Obtaining an accurate, timely IPF diagnosis is important given the
availability of new drugs that can slow the progression of this
debilitating disease, as well as the need to avoid inappropriate and
potentially harmful treatment,” said S. Samuel Weigt, M.D., M.S.,
associate professor of medicine at UCLA and director of UCLA Health’s
Interstitial Lung Disease Center. “Unfortunately, IPF is often difficult
to distinguish from other ILDs, even with the most advanced imaging
technologies. Further, diagnostic surgery is risky, expensive and may
not be viable for some patients. We are pleased to be one of the few
medical facilities in the country to have access to this breakthrough
technology.”

A recently
published study by the Pulmonary Fibrosis Foundation found that more
than half of patients with IPF or other ILDs were misdiagnosed at least
once and that, for four in 10 ILD patients, diagnosis took more than a
year. Among those patients with IPF, more than one in five reported
treatment during the diagnostic process with systemic corticosteroids, a
potentially harmful therapy for IPF patients.

The Envisia Genomic Classifier combines RNA sequencing and machine
learning to improve physicians’ ability to differentiate IPF from other
ILDs through patient samples that are obtained through transbronchial
biopsy, a nonsurgical procedure that is commonly used in lung
evaluation. The 190-gene test detects the genomic pattern of usual
interstitial pneumonia (UIP), a hallmark of IPF, with high accuracy (88
percent specificity and 70 percent sensitivity).

“Multiple studies have demonstrated that the Envisia Genomic Classifier
supports more confident IPF diagnosis and optimal patient management,”
said Bonnie Anderson, chairman and chief executive officer of Veracyte.
“We are honored to be working with physicians at leading institutions as
we begin making the test available to help ease what is often a
challenging diagnostic journey for patients with IPF or other ILDs. Our
Early Access Program – while limited to a small number of institutions –
will enable us to begin providing access to the test in advance of its
anticipated, nationwide commercial expansion in 2019.”

For more information about accessing the Envisia Genomic Classifier
through the Early Access Program, physicians and patients may contact
Veracyte at 844-464-5864 or support@veracyte.com.

About Interstitial Lung Disease

Each year in the United States and Europe, up to 200,000 patients are
evaluated for suspected interstitial lung disease (ILD), including IPF,
which is among the most common, deadly and difficult to diagnose of
these lung-scarring diseases. Physicians routinely use high-resolution
computed tomography (HRCT) along with a clinical work-up to help
identify IPF, but this approach frequently provides inconclusive
results, leading many patients to undergo invasive and potentially risky
surgery for a more definitive diagnosis. Other patients are too frail to
undergo surgery and may never receive an accurate diagnosis, which can
result in suboptimal - and potentially harmful - treatment.

About Veracyte

Veracyte, Inc. (Nasdaq: VCYT) is a leading genomic diagnostics company
that is providing trustworthy and actionable answers that fundamentally
improve patient care when current diagnostic tests are uncertain. The
company's products uniquely combine genomic technology, clinical science
and machine learning to provide answers that give physicians and
patients a clear path forward without risky, costly surgery that is
often unnecessary. Since its founding in 2008, Veracyte has
commercialized three genomic tests, which are transforming the diagnosis
of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis and
collectively target a $2 billion market opportunity. Veracyte is based
in South San Francisco, California. For more information, please visit www.veracyte.com
and follow the company on Twitter (@veracyte).

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genomic tests will transform the diagnosis of thyroid cancer, lung
cancer and idiopathic pulmonary fibrosis; statements regarding the
anticipated offerings under the launch of our Early Access Program; and
statements regarding the ability of the Envisia Genomic Classifier to
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